Royal Emerald Pharma DEA Controlled Substances Application
Summary
The Drug Enforcement Administration published notice that Royal Emerald Pharmaceuticals, 14011 Palm Drive, Building B, Desert Hot Springs, California 92240-6845, applied on March 3, 2026 to be registered as an importer of three Schedule I controlled substance basic classes: Marihuana Extract (7350), Marihuana (7360), and Tetrahydrocannabinols (7370). The company plans to import immature plants for continued cultivation under its Bulk Manufacturing registration. Registered bulk manufacturers and applicants may submit electronic comments or written hearing requests on or before May 18, 2026.
“Registered bulk manufacturers of the affected basic class(es), and applicants, therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before May 18, 2026.”
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What changed
DEA published notice of Royal Emerald Pharmaceuticals' March 3, 2026 application to register as an importer of three Schedule I controlled substances: Marihuana Extract (7350), Marihuana (7360), and Tetrahydrocannabinols (7370). The company seeks to import immature marijuana plants as starting materials for botanical raw materials and Active Pharmaceutical Ingredients under its existing Bulk Manufacturing registration. Registered bulk manufacturers of the affected basic classes and other interested parties may file electronic comments or written hearing requests by May 18, 2026.
Pharmaceutical manufacturers and researchers working with Schedule I controlled substances should note this application as it may affect market dynamics for marijuana-derived starting materials. Competitors and industry stakeholders have a 30-day window to file objections or request a hearing before the DEA considers the registration.
Archived snapshot
Apr 22, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Content
ACTION:
Notice of application.
SUMMARY:
Royal Emerald Pharmaceuticals has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer
to
SUPPLEMENTARY INFORMATION
listed below for further drug information.
DATES:
Registered bulk manufacturers of the affected basic class(es), and applicants, therefore, may submit electronic comments on
or objections to the issuance of the proposed registration on or before May 18, 2026. Such persons may also file a written
request for a hearing on the application on or before May 18, 2026.
ADDRESSES:
The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking
Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file
for lengthier comments. Please go to https://www.regulations.gov and follow the online instructions at that site for submitting comments. Upon submission of your comment, you will receive
a Comment Tracking Number. Please be
aware that submitted comments are not instantaneously available for public view on https://www.regulations.gov. If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit
the same comment. All requests for a hearing must be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ,
8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing should also be sent to: Drug Enforcement Administration,
Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION:
In accordance with 21 CFR 1301.34(a), this is notice that on March 3, 2026, Royal Emerald Pharmaceuticals, 14011 Palm Drive,
Building B, Desert Hot Springs, California 92240-6845, applied to be registered as an importer of the following basic class(es)
of controlled substance(s):
| Controlled substance | Drug code | Schedule |
|---|---|---|
| Marihuana Extract | 7350 | I |
| Marihuana | 7360 | I |
| Tetrahydrocannabinols | 7370 | I |
The company plans to import immature plants to use as starting/raw materials to continue cultivation of Marihuana under their
Bulk Manufacturing registration. All products and materials will be developed as botanical raw materials or Active Pharmaceutical
Ingredients for Drug Enforcement Administration-approved legitimate medical, scientific, research, and/or industrial purposes.
No other activities for these drug codes are authorized for this registration.
Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized
under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or non-approved
finished dosage forms for commercial sale.
Thomas Prevoznik, Deputy Assistant Administrator. [FR Doc. 2026-07561 Filed 4-16-26; 8:45 am] BILLING CODE 4410-09-P
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